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Last Updated: November 4, 2024

Metformin hydrochloride; rosiglitazone maleate - Generic Drug Details


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What are the generic drug sources for metformin hydrochloride; rosiglitazone maleate and what is the scope of freedom to operate?

Metformin hydrochloride; rosiglitazone maleate is the generic ingredient in two branded drugs marketed by Sb Pharmco and Teva, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Recent Clinical Trials for metformin hydrochloride; rosiglitazone maleate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
GlaxoSmithKlinePhase 1
Daiichi Sankyo, Inc.Phase 3
Daiichi Sankyo Inc.Phase 3

See all metformin hydrochloride; rosiglitazone maleate clinical trials

Paragraph IV (Patent) Challenges for METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
AVANDAMET Tablets metformin hydrochloride; rosiglitazone maleate 1 mg/ 500 mg, 2 mg/ 500mg 4 mg/ 500 mg 2 mg/ 1000 mg 4 mg/ 1000 mg 021410 1 2004-10-22

US Patents and Regulatory Information for metformin hydrochloride; rosiglitazone maleate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 077337-003 May 7, 2014 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-004 Aug 25, 2003 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-003 Oct 10, 2002 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-002 Oct 10, 2002 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 077337-005 May 19, 2017 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for metformin hydrochloride; rosiglitazone maleate

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